Job Title: Director - Quality Management Systems (QMS)

Location: Bangalore, India

Experience: 15+ Years

Industry: Healthcare, Life Sciences, Biomedical, or related domains

About Us:

We are a US-based healthcare product company committed to advancing patient outcomes through innovative medical technologies and digital health solutions. As part of our global expansion, we are establishing a leadership presence in India and seeking a seasoned professional to lead our Quality Management and Regulatory functions.

Position Overview:

The Director - QMS will play a strategic leadership role in establishing, managing, and continuously improving our global Quality Management System in alignment with international medical device regulations and standards. This role requires a dynamic leader with deep regulatory expertise, a strong quality mindset, and the ability to drive cross-functional collaboration across global teams.

Key Responsibilities:

1. QMS Leadership:

- Establish, implement, and maintain a compliant QMS aligned with ISO 13485, ISO 14971, IEC 62304, IEC 62366, and 21 CFR Part 11 / Part 820.

- Drive continuous improvement across the product lifecycle - from design and development to validation, deployment, and post-market activities.

- Oversee document control, CAPA, internal and supplier audits, risk management, and training programs.

- Ensure compliance readiness for both internal and external audits.

2. Regulatory Strategy & Submissions:

- Develop and execute global regulatory strategies for markets including the US (FDA), EU (MDR/IVDR), UK (MHRA), and India (CDSCO).

- Lead preparation and submission of regulatory dossiers such as 510(k), De Novo, CE Technical Documentation, and CDSCO Test/Manufacturing Licenses.

- Monitor regulatory intelligence, conduct gap assessments, and proactively adapt to evolving regulations in SaMD and AI/ML-based medical devices.

3. Cross-functional Collaboration

- Partner with R&D, Clinical, Product, and Commercial teams to ensure quality and regulatory compliance throughout the product lifecycle.

- Act as the primary liaison with regulatory authorities, notified bodies, and external auditors.

- Provide strategic guidance on compliance, risk management, and regulatory impact of business and product decisions.

4. Leadership & People Development

- Build, lead, and mentor a high-performing Quality & Regulatory team.

- Foster a culture of compliance, accountability, and continuous improvement.

- Coach and develop team members on regulatory and quality best practices aligned with global standards.

Qualifications & Experience:

- Master's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related discipline.

- 15+ years of progressive experience in medical device QMS and regulatory functions, with at least 5 years in leadership roles.

- Proven experience in QMS implementation and regulatory submissions for SaMD, digital health, or connected medical devices.

- In-depth understanding of ISO 13485, ISO 14971, IEC 62304, IEC 62366, GDPR, and HIPAA.

- Demonstrated success working with FDA, EU MDR/IVDR, and other global regulatory frameworks.

- Exceptional leadership, communication, and cross-functional collaboration skills.

Preferred Attributes:

- Experience in AI/ML-based SaMD regulatory considerations.

- Prior interaction with regulatory agencies and notified bodies.

- Ability to balance regulatory compliance with business agility in a fast-paced environment.